Healthy Skepticism Library item: 1105
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: media release
“Promoting Safe Prescription Drugs”
Drug Safety Canada 2005 Mar 16
Full text:
Drug Safety Canada
S.100 2030 Merchants Gate
Oakville, Ontario
Canada L6M 2Z8
“Promoting Safe Prescription Drugs”
Press Release
March 16, 2005 4 PM
Terence Young, Chair of Drug Safety Canada is calling for Health Minister Ujjal Dosanjh and Health Canada officials to direct Hoffman – La Roche Limited, the manufacturer of the weight loss drug Xenical to immediately discontinue their recent poster campaign designed to promote the diet drug Xenical, to place a special instructions on the Xenical official label, and to issue a medication guide to be given directly to patients that states:
1. Xenical is not considered to be safe and effective for cosmetic use.
2. Xenical could be dangerous for anyone with an eating disorder.
3. Xenical adverse effects include anal leakage (fecal incontinence) and oily spotting, and one out of four users who will suffer gas and anal discharge. (In clinical testing of Xenical 1/20 suffered infectious diarrhea)
This extraordinary warning is necessary says Young because Hoffman- LaRoche has been illegally promoting Xenical beyond what it is approved for in a series of billboards and posters across Canada – so called “off label” use – for cosmetic purposes. Xenical’s official label states: “Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m/square metre or over weight patients (BMI greater that 28kg/square metre) with associated risk factors.” Young states “Based on a chart on the Xenical web site, a woman who is 5’7”and weighs 110 lbs. – the body type depicted in Xenical posters – would have a body mass index (BMI) of about 17. Anyone with a BMI under 27 would have no medical need to take Xenical, and be taking an unjustified risk.”
However, the campaign which doesn’t mention the drug name but suggests women “ask their doctor” features slim women in sexy attire – a group for whom the risks of Xenical outweigh the benefits and asks what they would do with “a few pounds less”. The posters also neglect to mention the common adverse effects of Xenical. (listed above)
“We know that most doctors and few patients ever read the safety warnings or adverse effects on drug labels. An unknowing patient taking Xenical might look better in a bikini, but end up banned from the hotel pool. They should be properly warned of the adverse effects as well as the safety risks up front.” states Young. “We also believe Xenical should be contraindicated with eating disorders because it affects how food is absorbed in the body. Patients with eating disorders are already at risk of electrolyte disorders which can stop their heart. Yet Hoffman-LaRoche only mention eating disorders on their U.S. web site as something patients should tell their doctor. Off label drug use can be dangerous use – because the benefits of the drug are outweighed by the risks. Thousands of patients die every year in Canada from off-label use. Health Canada should put an end to this illegal promotion by Hoffman-LaRoche now.”
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Drug Safety Canada is a national non-profit patient advocacy group founded in 2002 to promote the safe use of prescription drugs. Drug Safety Canada is funded entirely through private donations and receives no funding from the pharmaceutical industry either directly or indirectly, or any government. Contact: Terence H. Young, Chair, Drug Safety Canada 905 842-5910 email: info@drugsafetycanada.com
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